All Regulatory Rapporteur articles in September 2023
View all stories from this issue.
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PodcastsRegRapPod − September 2023
Vol.20 #8: In the September 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Vickie Goff about globalisation and the supply chain.
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JournalQ&A:
Navigating the
pharmaceutical supply chainMatthew Scripps, Director, Supply Chain Planning, Mundipharma interviewed by Vickie Goff, TOPRA Editorial Board member
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EditorialThe worldwide web of regulation
In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...
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JournalRegulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Generics must demonstrate equivalence to the originator product to gain regulatory approval and market entry. There is a large market for generics that is predicted to continue to grow. The individual price of generics is lower than the originator, nevertheless manufacturers can avoid large development costs to bring generics to ...
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JournalNavigating the global supply of starting materials for cell-based therapies
The use of biological starting materials in the development of allogeneic cell-based therapies poses several challenges, whether due to availability of appropriate donors, complicated global logistics, or lack of global regulatory harmonisation around technical testing requirements. Sponsors must pay attention to adventitious agent safety requirements, which vary from region to region, and can also be affected by emerging disease threats, as was the case with the recent COVID-19 pandemic. Dr Elena Meurer, principal consultant and director at Biopharma Excellence, and Dr Jennifer Sales, consultant at Biopharma Excellence, explore these complexities.
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JournalBiosimilars CMC development considerations from the sponsor perspective
Sponsors face significant challenges in the development of biosimilars, particularly in the chemistry, manufacturing, and controls (CMC) aspects. Key areas of biosimilar CMC development include establishing a reliable and consistent manufacturing process, controlling critical quality attributes, and developing analytical methods to assess product quality. Furthermore, sponsors must conduct extensive characterisation studies, encompassing physicochemical and functional assays, to demonstrate biosimilarity between the biosimilar and the reference medicinal product (RMP). This article provides insights from a sponsor’s perspective, highlighting the challenges and opportunities associated with the biosimilar CMC development process. By adhering to these recommendations, sponsors can navigate the complexities of biosimilar development and enhance the likelihood of successful outcomes.
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JournalWarning letters for direct-to-consumer advertising: a five-year retrospective analysis
Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...
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